Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

In Brief: Device MRA talks

This article was originally published in The Gray Sheet

Executive Summary

Device MRA talks: FDA and European Union negotiators fail to resolve differences over a device mutual recognition agreement during round of talks in Brussels Jan. 6-10. The EU maintains its position that a device MRA include recognition of approvals and inspections, while FDA remains committed to an inspection-only pact. EU officials also are "rethinking" an agreement on pharmaceuticals forged during November's Trans-Atlantic Business Dialogue meeting in Chicago, according to Department of Commerce staffers. In a continued push to meet President Clinton's December pledge of finalizing an agreement by Jan. 31 ("The Gray Sheet" Dec. 23, p. 3), U.S. trade reps are inviting EU officials to Washington to resume talks. A meeting is expected to take place during the week of Jan. 27...

Latest Headlines
See All
UsernamePublicRestriction

Register

MT007414

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel